Smith & Nephew is providing this notice to advise users of its RENASYS EZ and RENASYS EZ Plus Negative Pressure Systems of a design modification to the bacterial overflow guard (filter) to reduce the potential of introducing air leakage in the vacuum circuit during system set-up and operation.

No removal of product distributed to the market is required and all canisters and bacterial overflow guards supplied by Smith & Nephew for use with RENASYS EZ/RENASYS EZ Plus systems can be used safely if they are used in accordance with the instructions in the supplied user manual.

A modification has been implemented to the bacterial overflow guard (filter) on all canisters made in October 2013 or later. The bacterial overflow guard (filter) assembly is supplied from the factory attached to the canister. Lot numbers for all product codes are assigned sequentially. Lot numbers that are lower than M400300 were manufactured with the original bacterial overflow guard (filter) subject to this notice.

Device users are reminded that reports of adverse events experienced with medical devices should be reported to FDA’s MedWatch Adverse Event Reporting program. Reports may be made online, by fax or by mail. Information regarding the MedWatch program and reporting instructions are available on FDA’s website at http://www.fda.gov/MedicalDevices/default.htm

For questions or additional information please contact Terry McMahon, Director of Regulatory Affairs and Quality, North America at 727-399-3785 or terry.mcmahon@smith-nephew.com.

URGENT: MEDICAL DEVICE SAFETY ALERT

June 26, 2009

Dear Valued Customer:

It has come to our attention that a customer has reported pieces of tissue remaining within Smith & Nephew Shaver Motor Drive Unit (Handpiece) after the cleaning process had been completed prior to sterilization. All personnel responsible for device cleaning and sterilization at your facility must be aware of and fully compliant with the following instructions, extracted from our current Instructions For Use for the Handpiece:

1. It is critical to observe the prescribed cleaning directions to thoroughly clean the devices.

2. As stated in Step 6 of the instructions, scrub all internal surfaces or holes with a tight-fitting brush using a twisting action. The brush should be of an appropriate size to ensure that the full depth of the area is reached.

Additional Information: If you have questions regarding this notice, please contact Smith & Nephew Endoscopy’s Technical Support at 800.343.5717 Option 2, between the hours of 8AM and 6PM EST.

Additional tips and recommendations for cleaning procedures including decontamination and sterilization of Smith & Nephew Endoscopy devices can be found on our website using the following link:Click here